Items | Specifications | Results |
Appearance | A white or almost white,crystalline powder | Whitecrystalline powder |
Solubility | Practically insoluble in water, sparingly soluble in acetone and in alcohol, slightly in methylene chloride | Complies |
Identification |
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A: IR-Spectrum | Meets the requirement | Complies |
B: HPLC | Meets the requirement | Complies |
Specific optical rotation | Between+162°and +168° | +165.4° |
Loss on drying | Not more than 1.0% | 0.09% |
Related substances |
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Impurity D RRT0.2 | Not more than 0.50% | 0.23% |
Impurity H RRT0.3 | Not more than 0.15% | N.D |
Impurity I RRT0.5 | Not more than 0.50% | 0.17% |
Impurity M RRT0.7 | Not more than 0.10% | 0.09% |
Impurity G RRT0.8 | Not more than 0.40% | 0.08% |
Impurity E RRT0.86 | Not more than 0.50% | 0.09% |
Impurity A RRT0.96 | Not more than 0.20% | 0.09% |
Impurity B RRT1.1 | Not more than 0.20% | N. D |
Impurity F RRT1.4 | Not more than 0.30% | 0.06% |
Impurity C RRT1.5 | Not more than 0.50% | 0.08% |
Impurity N RRT1.7 | Not more than 0.15% | N.D |
Any unspecified impurity | Not more than 0.10% | Complies |
Sum of impurities | Not more than 2.0% | 1.01% |
Assay | Between 97.0% and 103.0% | 100.7% |
Residual solvents (in-house) |
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|
Methanol | Not morethan 500ppm | Not detect out |
Ethanol | Not more than 2000ppm | Not detect out |
Methylene chloride | Not more than 600ppm | Not detect out |
Chloroform | Not more than 60ppm | Not detect out |
Particle size (In-house ) | 90% not more than 15micron | Complies |
Conclusion | The product conforms to Ph.Eur. 8.0 |
Hydrocortisone (English: hydrocortisone), also known as hydrocortisone or hydrocortisone, is the name of the hormone cortisol when it is used as a drug. It is sold by many pharmacists on the market [2] this drug can be used to treat such diseases as adrenal insufficiency, ...
Product Details Basic Info. Model NO.:50-03-3\\13609-67-1 Allias:Hydrocortisone 17-Butyrate; (11beta)-11, 21-Dihydr CAS:13609-67-1 Usage:Anti-Inflammatory Molecular Formula:C24h32o6 Assay:99% Apperance:White or Almost White Crystalline Powder Delivery Time:Within 24 Hours Upon ...